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February 20, 2012 12:42 PM | Posted by Wernette, Ronald | Permalink

You may be interested in a recent article in Product Liability Law360, February 2, 2012: "Mitigating Risk in Mass Nano Torts."

 

The article by attorneys Michael Lisak and James Mizgala (Sidley Austin LLP) suggests that consumer fraud (no-injury) class action claims are likely to be some of the first nanotechnology-related lawsuit faced by comapnaies making or selling nanomaterial-containing products. They suggest that the BPA plastic products liability class-action litigation can provide a useful framework for how similar nanoparticle claims may be pursued and defended.

Some excerpts are provided below, so you can decide whether to obtain the full article.

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February 14, 2012 1:21 PM | Posted by Wernette, Ronald | Permalink

The use of engineered nanoparticles in food processing and pharmaceuticals is increasing, but the impact of chronic oral exposure to nanoparticles on human health remains unknown.

It has been estimated that the average person in a developed country consumes over a trillion man-made fine to ultrafine particles every day. Some features of nanoparticles may lead to harmful interactions with cellular material but few if any studies have yet addressed the chronic effects of nanoparticle exposure on the normal function of the intestinal lining, known as the epithelium.  

"Oral exposure to polystyrene nanoparticles affects iron absorption", published on February 12, 2012, in the journal Nature Nanotechnology, addresses that issue.

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February 7, 2012 9:42 AM | Posted by Wernette, Ronald | Permalink

REACH, the European Union's primary regulation on chemicals is failing to identify or control nanomaterials. That is the conclusion of "Just Out of REACH: How REACH is failing to regulate nanomaterials and how it can be fixed," a report published February 6, 2012, by the nonprofit Center for International Environmental Law (CIEL).

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February 2, 2012 8:26 AM | Posted by Wernette, Ronald | Permalink

As discussed in a previous post, on December 28, 2011, the United States Environmental Protection Agency (EPA) proposed significant new use rules (SNURs) for 17 chemicals, more than a dozen of which were carbon nanotubes and fullerenes.

These new chemicals have already been allowed to go into production, but with protective measures outlined in consent orders or premanufacture notices filed by specific companies. The proposed rules adopt those conditions so they would apply to other manufacturers who want to make the substances.

The SNURs would require manufacturers to notify the EPA 90 days prior to beginning production of the intended new use, in order to give the agency time to determine if the way the manufacturers wanted to make or use the chemicals poses an unreasonable risk to people or the environment.

The new rules identify the concerns the EPA has with each of the chemicals, and the specific worker protection or protective actions required, if any. The absence of such protective measures, under the SNURs, would result in a significant new use designation.

Parties originally had until January 27, 2012, to submit comments on the proposed rules.  But the EPA has indicated that it will extend the comment period, probably to March 2012, following concerns voiced by unions and other groups.

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February 1, 2012 8:19 AM | Posted by Wernette, Ronald | Permalink

            

A coalition of government officials, chemical manufacturers, and representatives of labor and consumer advocacy groups are working together to come up with an agreement on ways to measure whether and how multiwalled carbon nanotubes are released from products embedded or coated with MWCNTs, potentially exposing workers, consumers or the environment.

The NanoRelease project is managed by the ILSI Research Foundation Center for Risk Science Innovation and Application (RSIA) and receives funding and technical support from U.S. and Canadian agencies, as well as industry associations.

It is acknowledged that major data gaps exist on the potential for nanoparticle release from products where nanomaterials have been embedded or coated onto a solid product.  But that type of information is critical for conducting real-world assessments of risk. 

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January 31, 2012 9:56 AM | Posted by Wernette, Ronald | Permalink

The January 2012 issue of the Defense Research Institute’s For The Defense magazine features the nanotechnology article "A Litigator's Guide to Health and Environmental Issues," by attorney John Delany, a member of Delany & O'Brien, in Philadelphia.

Delany describes the potential for what is now a limited series of commercial, patent, and regulatory legal battles to become full-blown personal injury tort litigation in the near future. Here is an excerpt:

The factors that could create a toxic, nanolitigation storm are (1) ubiquitous exposure; (2) sympathetic plaintiffs; (3) sensational press (4) reactive politicians; (5) product identification capability pointing to a specific product or a specific defendant; (5) biomarker and causation evidence; (6) corporate culpability; (7) state-of-the art medical and liability; (8) the serious, objective, potentially permanent nature of a potential injury due to nanomaterial exposure compared with potentially subjective transitory injury; (9) deep pockets of recovery; (10) product benefit-cost utility; and (11) warnings and personal choices involved with exposure.

In addition, judicial and legislative factors may affect the liability picture, including potential immunities, economic caps, limitations on punitive damages, joint and several liability, the collateral source rule, venue shopping, removal to a federal court, preemption, and the framework that the judiciary uses to manage and adjudicate claims, such as multi-district litigation processes.

 

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January 30, 2012 6:26 PM | Posted by Wernette, Ronald | Permalink

 

The federal government needs a better plan and additional funding to assess the environmental and health risks posed by nanomaterials, a National Research Council panel said in a report released on January 25, 2012.

The report, "A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials", was authored by the ad hoc NRC Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials.

The report of the 19-scientist Committee presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies – which does not currently exist.

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January 27, 2012 8:33 AM | Posted by Wernette, Ronald | Permalink

The Natural Resources Defense Council (NRDC) filed a federal suit against the U.S. Environmental Protection Agency on January 26, 2012, seeking to overturn EPA's decision to conditionally approve nanosilver under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It marks the first time ever that EPA's approval of a nanoscale chemical has been challenged in court. The NRDC petition was filed with the 9th U.S. Circuit Court of Appeals, headquartered in San Francisco, Calif.

The NRDC petition claims that sales of the nanosilver-based pesticide should be halted because the health risks of the substance are unknown. The environmental advocacy group, which has been highlighting potential safety concerns about the use of ultra-tiny silver particles as an antimicrobial agent for several years, accused the EPA of giving the manufacturer a “four-year free pass” by allowing the pesticide to come to market before health and safety testing has been completed.

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January 25, 2012 2:14 PM | Posted by Wernette, Ronald | Permalink

A project funded by the Danish Environmental Protection Agency (EPA), has resulted in the development of a new nanomaterial risk assessment tool called NanoRiskCat (NRC). The project's aim was to identify, categorize, and rank exposures and effects of nanomaterials used in consumer and industrial products based on data available in the peer-reviewed scientific literature and other regulatory relevant sources of information and data. The primary focus was on nanomaterials relevant for professional end-users and consumers, as well as nanomaterials released into the environment. The tool is a valuable step but needs to be further validated and tested on a series of various nano products in order to adjust and optimize the concept.

The project report, NanoRiskCat - A Conceptual Decision Support Tool for Nanomaterials, is 268-pages long.  I've provided what I hope is a succinct, but still sufficiently robust, summary of the NRC project and report below, from the report's Executive Summary. 

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January 16, 2012 5:10 PM | Posted by Wernette, Ronald | Permalink

On 12/20/11, the National Institute of Standards and Technology issued the world's first standard reference material for single-wall carbon nanotubes. 

NIST also issued a proposed material safety data sheet for single-wall carbon nanotubes.

Carbon nanotubes are the most commonly used nanomaterial in industrial applications and both the reference material and MSDS are important to companies that make or use single-wall carbon nanotubes. Having NIST's reference materials provides an important starting point for companies developing their own SWCNTs or developing applications for existing SWCNTs.

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January 11, 2012 4:07 PM | Posted by Wernette, Ronald | Permalink

In a new report, “The Sourcing Framework for Food and Food Packaging Products Containing Nanomaterials”, by the United States-based non-profit organization, As You Sow, sxperts in environmental health issues teamed with major companies to advise food industries to exercise caution when using nano-sized, manmade creations as nutritional additives, flavorings, colorings, or anti-bacterial coatings for packaging.

As You Sow teamed up with several major food companies, including Kraft, McDonald’s, Whole Foods, Yum! Brands, and Pepsi, to create the Framework. According to the study, as "food and food packaging companies explore the use of nanomaterials to enhance products, they need also attend to potential risks introduced."

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January 6, 2012 8:43 AM | Posted by Wernette, Ronald | Permalink

     

The Innovation Society and Marsh Risk Consulting will be holding a free webinar (English language), “Managing Nano Risk – Implementation of a Risk Management System for Nanomaterials,” on February 23, 2012.

For a company with a connection to nanomaterials, and its insurers, it is difficult to judge whether there are hidden risks to workers or customers due to uncertainty in health, safety and environmental (HSE) data. Furthermore it is difficult for a company to anticipate the future development in nanomaterials regulation globally. The webinar aims to provide useful information about those issues.

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